<p>This document specifies requirements for the <em>basic safety</em> and <em>essential performance</em> of an <em>oxygen</em> <em>concentrator</em> in combination with its <em>accessories</em>, hereafter referred to as <em>ME equipment, </em>intended to increase the oxygen concentration of gas intended to be delivered to a single <em>patient</em>. Such <em>oxygen</em> <em>concentrators</em> are typically intended for use in the <em>home healthcare environment</em> by a single <em>patient</em> in various environments including any private and public transportation as well as in commercial aircraft.</p>
<p>NOTE 1 Such <em>oxygen concentrators</em> can also be used in professional healthcare facilities<em>.</em></p>
<p>This document is applicable to a <em>transit-operable </em>and non-<em>transit-operable oxygen</em> <em>concentrator.</em> This document is applicable to an <em>oxygen concentrator</em> integrated into or used with other medical devices, <em>ME equipment</em> or <em>ME systems.</em></p>
<p>EXAMPLE 1 An <em>oxygen concentrator</em> with integrated oxygen <em>conserving equipment</em><sup> </sup> function or humidifier function.</p>
<p>EXAMPLE 2 An <em>oxygen concentrator</em> used with a flowmeter stand.</p>
<p>EXAMPLE 3 An <em>oxygen concentrator</em> as part of an anaesthetic system for use in areas with limited logistical supplies of electricity and anaesthetic gases<sup>[2]</sup>.</p>
<p>EXAMPLE 4 An <em>oxygen concentrator</em> with an integrated liquid reservoir function or gas cylinder filling system function.</p>
<p>This document is also applicable to those <em>accessories</em> intended by their <em>manufacturer</em> to be connected to an <em>oxygen</em> <em>concentrator</em>, where the characteristics of those <em>accessories</em> can affect the <em>basic safety</em> or <em>essential performance</em> of the <em>oxygen</em> <em>concentrator</em>.</p>
<p>NOTE 2 Such <em>accessories</em> can include, but are not limited to, masks, cannulae, extension tubing, humidifiers, carts, carrying cases, external power sources and oxygen <em>conserving equipment.</em></p>
<p>This document does not specify requirements for <em>oxygen</em> <em>concentrators </em>for use with a <em>medical gas pipeline system</em>.</p>
<p>If a clause or subclause is specifically intended to be applicable to <em>ME equipment</em> only, or to <em>ME systems</em> only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to <em>ME equipment</em> and to <em>ME systems</em>, as relevant.</p>
<p><em>Hazards</em> inherent in the intended physiological function of <em>ME equipment</em> or <em>ME systems</em> within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard.</p>
<p>NOTE 3 See also 4.2 of the general standard.</p>
Registration number (WIID)
87164
Scope
<p>This document specifies requirements for the <em>basic safety</em> and <em>essential performance</em> of an <em>oxygen</em> <em>concentrator</em> in combination with its <em>accessories</em>, hereafter referred to as <em>ME equipment, </em>intended to increase the oxygen concentration of gas intended to be delivered to a single <em>patient</em>. Such <em>oxygen</em> <em>concentrators</em> are typically intended for use in the <em>home healthcare environment</em> by a single <em>patient</em> in various environments including any private and public transportation as well as in commercial aircraft.</p>
<p>NOTE 1 Such <em>oxygen concentrators</em> can also be used in professional healthcare facilities<em>.</em></p>
<p>This document is applicable to a <em>transit-operable </em>and non-<em>transit-operable oxygen</em> <em>concentrator.</em> This document is applicable to an <em>oxygen concentrator</em> integrated into or used with other medical devices, <em>ME equipment</em> or <em>ME systems.</em></p>
<p>EXAMPLE 1 An <em>oxygen concentrator</em> with integrated oxygen <em>conserving equipment</em><sup> </sup> function or humidifier function.</p>
<p>EXAMPLE 2 An <em>oxygen concentrator</em> used with a flowmeter stand.</p>
<p>EXAMPLE 3 An <em>oxygen concentrator</em> as part of an anaesthetic system for use in areas with limited logistical supplies of electricity and anaesthetic gases<sup>[2]</sup>.</p>
<p>EXAMPLE 4 An <em>oxygen concentrator</em> with an integrated liquid reservoir function or gas cylinder filling system function.</p>
<p>This document is also applicable to those <em>accessories</em> intended by their <em>manufacturer</em> to be connected to an <em>oxygen</em> <em>concentrator</em>, where the characteristics of those <em>accessories</em> can affect the <em>basic safety</em> or <em>essential performance</em> of the <em>oxygen</em> <em>concentrator</em>.</p>
<p>NOTE 2 Such <em>accessories</em> can include, but are not limited to, masks, cannulae, extension tubing, humidifiers, carts, carrying cases, external power sources and oxygen <em>conserving equipment.</em></p>
<p>This document does not specify requirements for <em>oxygen</em> <em>concentrators </em>for use with a <em>medical gas pipeline system</em>.</p>
<p>If a clause or subclause is specifically intended to be applicable to <em>ME equipment</em> only, or to <em>ME systems</em> only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to <em>ME equipment</em> and to <em>ME systems</em>, as relevant.</p>
<p><em>Hazards</em> inherent in the intended physiological function of <em>ME equipment</em> or <em>ME systems</em> within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard.</p>
<p>NOTE 3 See also 4.2 of the general standard.</p>
